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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a report, two patients were described, of whom a woman in her fifties [age at reaction onset not stated] developed recurrence of melanoma following treatment with fludarabine, cyclophosphamide, rituximab, navitoclax, alemtuzumab and ciclosporin, while a man in his sixties [age at reaction onset not stated] developed recurrence of melanoma following treatment with cyclophosphamide, vincristine, fludarabine, alemtuzumab, tacrolimus, mycophenolate and unspecified steroids [routes and dosages not stated; not all durations of treatments to reactions onsets stated].
Case 1: A woman in her fifties, who had been diagnosed with chronic lymphocytic leukaemia (CLL) in 2001, started receiving treatment with fludarabine, cyclophosphamide and rituximab (FCR regimen). Prior to the...
- Stevens H, et al. Allogeneic stem cell transplantation as a risk factor for recurrent melanoma. Leukemia and Lymphoma 59: 1750-1752, No. 7, Jul 2018. Available from: URL: http://doi.org/10.1080/10428194.2017.1393670 - Australia